Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves

Coronary Artery Disease Clinical Trial

Official title:

Identifying Optimal Cooling Strategies for Coronary Artery Disease Patients During Heatwaves

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03832504
• Other study ID #: ICM 2019-2425
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: June 23, 2021

Study information

• Verified date: July 2023
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the optimal cooling strategies to alleviate cardiovascular strain of coronary artery disease individuals during a simulated North American and Australian heatwave.

Description:

Globally, heatwaves are occurring more frequently, are of greater intensity and longer in duration. The devastating health impacts of extreme heat are increasingly recognized, particularly in vulnerable populations, such as adults with coronary artery disease (CAD). While the most effective cooling strategy during a heatwave is the use of air conditioning (AC), economical concerns can limit AC use among vulnerable populations. In addition, widespread AC use places a significant burden on the electrical grid, causing brown-outs and black-outs during periods of extreme heat.

Electric fans offer a cooling strategy with a 50-fold lower power requirement and cost compared to AC. However, the efficacy of fan use during heat waves remains contentious. The primary objective of this study is to identify the optimal cooling strategy to alleviate cardiovascular strain of CAD patients exposed to typical North American heatwave conditions (38°C with 60% relative humidity). The secondary objective is to identify the optimal cooling strategy to alleviate cardiovascular strain of CAD patients exposed to typical Australian heatwave conditions (46°C with 10% relative humidity).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• History of angiographic coronary disease (=70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or stable angina and/or perfusion defect during exercise testing.

• No CAD-related hospitalisations or changes in cardiac medications or change in pattern of angina for at least 3 months prior to enrolment

Exclusion Criteria:

• Body mass index =35 kg/m2.

• Currently undertaking estrogen therapy.

• Evidence of current fluid and electrolyte disorders, anemia, abnormal thyroid function, arrhythmias, diabetes, renal disease, liver disease, cerebrovascular disease, significant pulmonary disease, endocrine abnormalities, significant cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition or any other medical condition deemed to pose risk during the proposed experiments.

• Uncontrolled hypertension (>180/110 mmHg).

• Recent (<3 months) coronary bypass surgery.

• Ejection fraction <40% and/or clinical evidence/history of heart failure.

• Significant valvular heart disease

• Resting ECG abnormalities interfering with observation of ST segment changes during testing.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• No intervention
The participant will rest in a seated position.
• Fan
A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.
• Skin Wetting
Tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.
• Fan + Skin wetting
A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure. In addition, tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.

Locations

Country	Name	City	State
Canada	cardiovascular Prevention and rehabilitation Centre of the Montreal Heart Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin temperature	In degrees Celcius	Change from baseline to the end of the 3 hour exposure
Other	Sweat loss	In kilograms	Change from baseline to the end of the 3 hour exposure
Other	Local sweat rate	In mg per minute per cm2	Measured continously during the 3 hour exposure
Other	Skin blood flow	In arbitrary perfusion units	Measured continously during the 3 hour exposure.
Primary	Rate pressure product	Rate pressure product, in beats per minute per mmHg	Change from baseline to the end of the 3 hour exposure
Secondary	Body core temperature	In degrees Celcius	Change from baseline to the end of the 3 hour exposure